Teleflex Medical, LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000023660 FEI 3005747797
Part of Teleflex Medical
- Devices
- 116
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
What Teleflex Medical, LLC makes
Teleflex Medical, LLC manufactures orthopedic fixation products, including polyethylene-based materials such as Polyethylene Fusion and Polyethylene OrthoTape™, as well as the MANTA™ Vascular Closure Device for post-procedural hemostasis in vascular access sites.
The company’s portfolio includes devices regulated as Class II and Class III under FDA authorities, with submissions recorded via 510(k) clearances and Premarket Approval Applications (PMA). These products are listed in the FDA’s regulatory databases.
Catalogue
Search and filter all 116 devicesShowing 1-50 of 116
Company details
- EUDAMED SRN
- US-MF-000023660
- FDA FEI number
- 3005747797
- EUDAMED status
- Active
- EUDAMED registered name
- Teleflex Medical LLC.
- Registered address
- 3015, Carrington Mill Blvd, 27560, Morrisville, United States
- [email protected]
- Phone
- 353 (0) 9 06 46 08 00
- PRRC contact
- Marisa Walsh
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 13 Feb 2028
Notified body 2797 1 certificate
- MDR 752387 Active
Quality management system EU MDR
- Issued
- 29 Sep 2026
- Expires
- 13 Feb 2028
- Reason
- Change approved
Frequently asked questions
How many devices does Teleflex Medical, LLC have in the registry?
The registry currently lists 116 devices for Teleflex Medical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Teleflex Medical, LLC's devices?
Among its 50 most recently registered devices, Teleflex Medical, LLC has devices listed in EUDAMED (49 devices), FDA 510(k) (1 device) and FDA GUDID (17 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Teleflex Medical, LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Teleflex Medical, LLC's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Teleflex Medical, LLC?
EUDAMED lists 1 certificate for Teleflex Medical, LLC (quality management system) under MDR. The most recent was issued on 2026-09-29.
What are the newest devices from Teleflex Medical, LLC in the registry?
The most recently registered devices listed for Teleflex Medical, LLC include ONCONTROL BONE LESION BIOPSY TRAY, 10/12 ga 15/19 cm, MANTA 14F Depth Locator, HEM-O-LOK APPLIER MEDIUM LARGE 8" CURVED REFURBISHED and HEM-O-LOK APPLIER EXTRA LARGE 11" CURVED REFURBISHED.